PF-Labetalol HCl Injection — Class II drug recall D-0064-2023
Terminated recall by Nephron Sterile Compounding Center LLC, reported 2022-11-23, distributed nationwide. CGMP Deviations: Potential for cross contamination due to product carry over.
| Recall number | D-0064-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sterile Compounding Center LLC, West Columbia, SC, United States |
| Recall initiated | 2022-11-10 |
| Classified | 2022-11-17 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2024-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 34,020 vials |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00369374946346 |
| NDC | 69374-0946-34 |
| Lot numbers | LB2001B, LB2005B |
| Expiration dates | 2023-01-07, 2023-03-02 |
Product
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Reason for recall
CGMP Deviations: Potential for cross contamination due to product carry over.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0064-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.